Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited
[2018] APO 11
•21 February 2018
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited
[2018] APO 11
Patent Application: 2008322739
Title:Use of anti-bacterial compounds having an anaesthetic effect
Patent Applicant: Reckitt Benckiser Healthcare (UK) Limited
Opponent: Sanofi-Aventis Healthcare Pty Limited
Hearing Officer: Dr S. D. Barker – Deputy Commissioner of Patents
Decision Date: 21 February 2018
Hearing Date: 22 November 2017, in Canberra
Catchwords: PATENTS – section 59 opposition to grant of a patent – manner of manufacture – lack of manner of manufacture not established – utility – lack of utility not established – novelty – lack of novelty by prior use of Strepsils® lozenges – inevitable result – inventive step – lack of inventive step in view of Strepsils® lozenges – clarity – lack of clarity not established – fair basis – lack of fair basis for general anaesthesia – full description – lack of full description not established
Representation: Patent attorney for the applicant: Dr Jeff Holman and Dr Michael Dow of Madderns Patent & Trade Mark Attorneys
Counsel for the opponent: Ms Helen Rofe SC
Patent attorney for the opponent: Ms Karen Sinclair and Dr Chris Vindurampulle of Watermark Patent & Trade Mark Attorneys
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2008322739
Title:Use of anti-bacterial compounds having an anaesthetic effect
Patent Applicant: Reckitt Benckiser Healthcare (UK) Limited
Date of Decision: 21 February 2018
DECISION
The opposition succeeds: claims 12-19 lack novelty; claims 12-19 lack inventive step; and claims 1-5 lack fair basis.
I allow Reckitt Benckiser Healthcare (UK) Limited two (2) months from the date of this decision to propose amendments to overcome these grounds.
I award costs according to Schedule 8 against Reckitt Benckiser Healthcare (UK) Limited.
REASONS FOR DECISION
Background
Patent application 2008322739 in the name of Reckitt Benckiser Healthcare (UK) Limited (the Applicant) was advertised as accepted on 10 July 2014. Sanofi-Aventis Healthcare Pty Limited (the Opponent) opposed the grant of a patent under section 59 of the Patents Act (the Act), and the opposition was heard on 22 November 2017.[1] The Applicant was represented by Dr Jeff Holman and Dr Michael Dow of Madderns Patent & Trade Mark Attorneys. The Opponent was represented by Ms Helen Rofe SC of counsel, assisted by Ms Karen Sinclair and Dr Chris Vindurampulle of Watermark Patent & Trade Mark Attorneys.
[1] The Applicant filed amendments on 28 September 2015 (the amendments) which were opposed by the Opponent on 6 January 2016. The amendments were allowed in the decision reported as [2016] APO 86. Consequently the specification for the purposes of this decision includes the amendment.
The opposition
The statement of grounds and particulars identifies nine grounds of opposition: manner of manufacture, novelty, inventive step, utility, full description, best method of performance, clarity, claims do not define the invention, and fair basis. At the hearing, only seven grounds were pressed: manner of manufacture, novelty, inventive step, utility, full description, clarity and fair basis.
The parties relied upon evidence by several declarants. Evidence in support consists of declarations by David Adams (Adams-1 and Adams-2), Macdonald Christie (Christie-1 and Christie-2), Michael Conos (Conos), and David Ford (Ford). Evidence in answer consists of declarations by Martin Leuwer (Leuwer), Joseph William Lynch (Lynch) and Yen Trieu (Trieu-1 and Trieu-2). Evidence in reply consists of declarations by David Adams (Adams-3) and Macdonald Christie (Christie-3).
The request for examination in relation to the patent application was filed on 1 June 2012. As a consequence, the substantive amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the opposed application. This includes the amendment to section 60(3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition has been made out. Instead, the onus of proof in this opposition proceedings lies with the Opponent, who must establish that it is clear that a valid patent cannot be granted.[2]
[2] F. Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67], 50 IPR 305; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22], 79 IRP 426.
The specification
The opposed application claims priority from GB 0722349.8 filed on 15 November 2007, the contents of which are incorporated into the present specification by reference. The specification as amended on 28 September 2015 comprises description pages from 1 to 21, claims pages 22 and 23, and drawing pages from 1/10 to 10/10. There are 19 claims, including eight independent claims (claims 1, 2, 7, 8, 12, 13, 17 and 18). The claims in full appear in the ANNEX at the end of this decision.
What is the invention as described
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd:[3]
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”
[3] [2013] FCA 214, 100 IPR 451 at [139].
The background to the invention
The application is titled “Use of anti-bacterial compounds having an anaesthetic effect”. The invention is broadly summarised at the beginning of the specification as follows:
“In particular, the present invention is directed to the use of 2,4-dichlorobenzyl alcohol (DCBA), amylmetacresol (AMC), cetyl pyridinium chloride (CPC) and hexetidine (HT) to achieve an anaesthetic effect.”[4]
[4] Specification at page 1, lines 4-6.
The specification then proceeds to detail some of the known uses of the compounds of the invention. The specification states that “2,4-dichlorobenzyl alcohol (DCBA) is a well-known anti‑bacterial compound, and is used against a number of gram positive and gram negative bacteria.”[5] The specification then discloses the prior art uses of DCBA for the treatment of plaque,[6] as part of an antimicrobial composition for sterilizing surgical equipment,[7] for the treatment of gastric disorders,[8] in combination with AMC for the treatment of HIV[9] and SARS,[10] and for the treatment of inflammation of skin or mucosa.[11] The specification also discloses the use of AMC in an anti-microbial composition.[12] The specification further discloses the use of CPC in oral rinses for cleaning the mouth and treating minor throat or mouth infections and teething problems, as well as an ingredient in certain pesticides.[13] The specification further discloses the use of HT in oral rinses for cleaning the mouth and treating minor throat or mouth infections.[14] At page 21, the specification concludes by stating all publications mentioned in the specification are incorporated by reference.
[5] Specification at page 1, lines 8-9.
[6] EP 0161898.
[7] US 4167583.
[8] WO 1992/018111.
[9] WO 1996/032934.
[10] WO 2005/067906.
[11] US 6251371.
[12] US 2007/0202177.
[13] Specification at page 1, lines 27-29.
[14] Specification at page 2, lines 1-2.
The specification states on page 2, lines 6-7 that:
“[v]iral sore throats [as opposed to bacterial sore throats] … do not respond to antibiotics, and therefore management of the symptoms is required until the virus has been eliminated from the body.”
The specification provides some guidance on the meaning of the word anaesthesia:
“Anaesthesia is generally considered to be the loss or absence of sensation or feeling. The term is commonly used to describe a reversible process which allows operations and painful or unpleasant procedures to be performed without distress to the patient. … Unlike local anaesthetics [analgesics] … produce no sensory or motor blockade stopping the activity in the sensory or motor nerves”.[15]
[15] Specification at page 2, lines 18-23.
The specification proceeds to identify two aspects of the invention in the following terms:
“According to a first aspect of the present invention there is provided the use of 2,4-dichlorobenzyl alcohol for the preparation of a medicament for the provision of an anaesthetic effect, wherein the medicament comprises a combination of 2,4-dichlorobenzyl alcohol with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride and hexetidine.”[16]
“According to a second aspect of the present invention there is provided a method of obtaining a local anaesthetic effect in a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol which exhibits an anaesthetic effect.”[17]
[16] Specification at page 3, lines 3-6.
[17] Specification at page 3, lines 17-19.
Under the first aspect, the specification identifies the form of the medicament, most preferably a lozenge,[18] as well as the conditions the medicament can be used to treat. These conditions include dry, scratchy, inflamed, swollen, stabbing, burning and painful sore throats, as well as the treatment of other areas of the mouth such as the gums or tonsils.[19]
[18] Specification at page 3, line 9.
[19] Specification at page 3, lines 12-14.
The specification states that the medicaments comprise DCBA in a combination with AMC, CPC, HT and hexylresorcinol (HR), and that they may be prepared using methods known to those skilled in the art, for example, by admixing the active ingredients with suitable carrier(s) or excipients(s) under sterile conditions.[20]
[20] Specification at page 3, line 24 – page 4, line 2.
Concentrations
The specification states that the concentrations of the components of the medicaments or compositions described may vary according to the particular requirements of the medication or composition, providing the medicament or composition is safe for human use and provides an anaesthetic effect.[21]
[21] Specification at page 4, lines 2-5.
The specification provides embodiments where the medicament is in the form of a suckable or masticable solid dosage form (i.e. a lozenge). In some embodiments the DCBA is present in an amount greater than or equal to 0.2mg, or greater than or equal to 0.5mg, or greater than or equal to 1.0mg, or greater than or equal to 1.5mg based on the total weight of the medicament. In other embodiments the DCBA is present in an amount of less than or equal to 5mg, or less than or equal to 3mg, or less than equal to 2mg, or less than or equal to 1.75mg based on the total weight of the medicament. In a still preferred embodiment, DCBA is present in an amount of 1.2mg.[22]
[22] Specification at page 4b, lines 17-24.
The specification provides further embodiments wherein the medicament is in a lozenge form, and AMC is present in an amount greater than or equal to 50µg, or greater than or equal to 100µg, or greater than or equal to 250µg, or greater than or equal to 500µg based on the total weight of the medicament. In alternative embodiments, AMC is present in an amount of less than or equal to 1,500µg, or less than or equal to 1,000µg, or less than or equal to 800µg, or less than or equal to 700µg based on the total weight of the medicament. In a still preferred embodiment, AMC is present in an amount of 0.6mg.[23]
[23] Specification at page 4b, line 25-page 4c, line 2.
It is interesting to note that the most preferred form of the medicament is in the form of a lozenge comprising 1.2mg of DCBA and 0.6mg of AMC, which are the identical amounts of the same two compounds in Strepsils® lozenges. This fact was not in dispute.
The specification at page 4d provides a typical medicament consisting essentially of:
Ingredient wt%
(a)Acid 0.2 to 0.6
(b)DCBA 0.02 to 0.10
(c)AMC 0.01 to 0.05
(d)Excipients (flavouring, colouring, preservatives, etc.) 0.1 to 1.5
(e)Sugar or sugar alcohol base Balance of composition,
typically greater than or equal to 97% by weight
(f)Water Up to 4% by weight, preferably 1 to 3% by wt
Mode of delivery
The specification states that the medicament can be provided to a patient suffering from a sore throat, including dry, scratchy, inflamed, swollen, stabbing, burning and painful throats, or the patient may be suffering from infection of other areas of the mouth such as the gums or tonsils.[24] The specification also states that the medicament may be adapted to be delivered to a patient by any suitable route. In one embodiment, the medicament is delivered orally or topically.[25]
[24] Specification at page 5, lines 1-3.
[25] Specification at page 4e, lines 7-8.
Figures/ Examples
Embodiments of the invention are described, by way of example only, with reference to accompanying Figures 1-19.[26] The figures detail the experiments that were conducted to act as a model for whether the medicament was providing an anaesthetic effect. Stably transfected HEK 293 cell lines expressing the α-subunit of Nav1.2 neuronal sodium channels from a rat were used.[27] Standard whole-cell voltage-clamp experiments were performed.[28] The figures provide concentration response curves for AMC (Figure 1), DCBA (Figure 4), CPC (Figure 8), HT (Figure 11), and HR (Figure 17). The experiments also measure binding affinities with fast inactivation- voltage-dependence of block by AMC (Figure 2) and DCBA (Figure 5). An experiment was also performed to measure the concentration- and voltage-dependent increase in blocking potency of AMC (Figure 3). Figures 7, 9 and 12 illustrate fast inactivation effects of AMC/DCBA, CPC and HT respectively, and Figure 6 illustrates the effects of a combination of AMC and DCBA. Figures 10, 13 and 19 illustrate fast inactivation current traces for CPC, HT and HR respectively. Figures 14-16 illustrate estimated affinities of AMC, DCBA and HT to inactivated channels, and Figure 18 illustrates the concentration dependent increase in binding affinity with fast inactivation: voltage dependence of sodium channel block by HR. Table 1 discloses the half‑maximum blocking concentrations and Hill coefficients for resting and inactivated state binding of AMC, DCBA, CPC, HR and HT.[29]
[26] Specification at page 5, line 5 – page 6, line 18.
[27] Specification at page 6, lines 21-22.
[28] Specification at page 7, line 7.
[29] Specification at page 18.
The experiments conducted identified the blocking effects of AMC, DCBA, CPC, HR and HT on heterologously expressed voltage-gated neuronal sodium channels.[30] Of all compounds studied, CPC showed the highest potency to block sodium inward current upon depolarization from hyperpolarized potentials.[31] The results show that block induced by CPC is concentration‑dependent, but not voltage-dependent (Figure 11, 12, 13).
[30] Specification at page 18, lines 17-19.
[31] Specification at page 18, lines 19-21.
The specification shows that AMC, DCBA and HT block sodium inward currents in a voltage- and concentration-dependant manner.[32] DCBA possessed the lowest potency for blockade of sodium currents of all compounds studied, comparable to the blocking potency of the local anaesthetic lidocaine.[33] The specification identifies that AMC and HR are the compounds which most resemble lidocaine-like local anaesthetics with respect to higher binding affinity to inactivated channels than to resting channels.[34] The EC50 for block of sodium channels upon depolarization from the resting state for AMC was 55µM, around 10 fold higher than the respective potency of lidocaine.[35] The specification further identifies an increase in blocking potency of 30µM AMC by addition of 60µM DCBA, and even a decrease in blocking potency of 50µM AMC by the addition of 100µM DCBA (Figures 6-7).
[32] Specification at page 19, lines 2-3.
[33] Specification at page 19, lines 3-5.
[34] Specification at page 19, lines 20-21.
[35] Specification at page 19, lines 22-23.
Among the compounds studied, AMC is around 10-fold more potent than lidocaine, and DCBA is about as potent as lidocaine with respect to the block of resting channels.[36] Finally, addition of DCBA to AMC decreases the effect of AMC applied as the sole drug.[37]
[36] Specification at page 20, lines 15, 16, 18 and 19.
[37] Specification at page 20, lines 20-21.
The Problem
The specification does not explicitly identify the problem overcome by the current invention. The specification alludes to the fact that the discomfort associated with sore throats is a problem, in particular viral sore throats do not respond to antibiotics and symptoms have to be managed until the virus has been eliminated from the body.[38]
[38] Specification at page 2, lines 4-7.
The Opponent submits that the problem is “whether compounds such as AMC and DCBA were capable of exhibiting anaesthetic effects.”[39]
[39] Opponent’s Written Submissions at [130].
The Applicant disagrees arguing:
“There is no such ‘problem’ mentioned in the specification. The background of the specification discusses known uses of DCBA, AMC, CPC and HT, none of which have anything to do with anaesthesia. The background of the specification discusses the known anaesthetics benzocaine and lidocaine hydrochloride. The Opponent has impermissibly used the benefit of hindsight in formulating the specified problem.”[40]
[40] Applicant’s Written Submissions at [174].
I agree with the Applicant that the Opponent’s formulation of the problem uses improper hindsight, as there is nothing in the specification to suggest the problem is whether compounds such as AMC and DCBA were capable of exhibiting an anaesthetic effect. To the contrary, the specification identifies the known uses of AMC and DCBA, and none of these relate to anaesthesia. I consider the problem to be the need for a fast acting method to manage the discomfort associated with a sore throat. There is a need to manage the symptoms of a sore throat until antibiotic treatment begins to take effect, or in the case of a viral sore throat, until the virus has been eliminated from the body.
The Person Skilled in the Art
The person skilled in the art (PSA) was considered in Root Quality Pty Ltd v Root Control
Technologies Pty Ltd:[41]
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”
[41] [2000] FCA 980; 49 IPR 225 at [70].
However, the PSA is not a real person, but an artificial construct that is used as a tool of analysis which is used to make the determination:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”[42]
[42] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30; 257 CLR 356 at [23].
The Opponent submits that the PSA is a person who has a detailed understanding of nociception at the molecular level,[43] and does not accept that the Applicant’s expert, Professor Lynch, was relevantly qualified as at the priority date as his major research interest is in glycine and GABAA receptor chloride channels, which function differently to Navs and are not implicated in nociception and pain.[44]
[43] Opponent’s Written Submissions at [49].
[44] Opponent’s Written Submissions at [51].
The Applicant submits that the PSA is drawn from “a class of persons who are knowledgeable about and aware of developments in the field of the use of anaesthetics to areas of the mouth of patients, including the throat, gums and tonsils.”[45] The Applicant relies on the evidence of Ms Trieu as being representative of the person skilled in the art as Ms Trieu has qualifications and experience in pharmacy before the priority date of the opposed application.[46] The Applicant further relies on the evidence of Professor Lynch and Professor Leuwer, to address the Opponent’s evidence in relation to the physiology of sodium gated ion channels.[47]
[45] Applicant’s Written Submissions at [28].
[46] Applicant’s Written Submissions at [29].
[47] Applicant’s Written Submissions at [29].
The Applicant further submits that:
“the person skilled in the art in the present case is not a neurophysiologist (Professor Adams) or a neuropharmacologist (Professor Christie) … as neurophysiologists, neuropharmacologists, neuroscientists and the like are engaged in research at a molecular level and generally in an academic setting. There is no evidence that Professor Adams and Christie have the requisite professional experience or knowledge about developments in the field of anaesthetics and their practical, real world use in the provision of anaesthesia to areas of the mouth of patients, including the throat, gums and tonsils.”[48]
[48] Applicant’s Written Submissions at [30].
The Applicant seeks to draw analogy with Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4)[49] (Otsuka), submitting that “the Court warned that it is not permissible for the person skilled in the art to be differently constituted depending on whether the task for that person is the construction of documents or … considering whether an invention as claimed is obvious.”[50] The Applicant further submits that in Otsuka, the PSA was a team comprising all practical “end users” (a psychiatrist in clinical practice, a psychopharmacologist and a medicinal chemist) of the claimed invention, and not neurophysiologists and the like who worked at the molecular level.[51]
[49] [2015] FCA 634; 113 IPR 191.
[50] Applicant’s Written Submissions at [31].
[51] Applicant’s Written Submissions at [32].
The Opponent submitted at the hearing that researchers in the broad field of electrophysiology would be required in the hypothetical team encompassing the PSA, as such team members would be required to construe the disclosure of the specification (in particular the experiments described on pages 5-21). I agree with this submission and am satisfied that the hypothetical team representing the PSA would comprise medical practitioners, pharmacists and researchers in the field of electrophysiology. I consider that all of the declarants are suitably qualified to provide evidence as to what was known by the PSA.
Construction
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:[52]
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee’s choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification”.
[52] [2009] FCAFC 70, 81 IPR 228 at [118]-[120].
Construction of claim 1
Claim 1 is the first independent claim. It reads:
“The use of 2,4-dichlorobenzyl alcohol in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol for the preparation of a medicament for the provision of an anaesthetic effect.”
Claim 1 is drafted in the form of a Swiss type claim.[53] Yates J in Otsuka at [120] stated:
“In my view, an invention defined by a Swiss type claim is appropriately characterised as a method or process.”
[53] The generalised form of a Swiss type claim is “the use of compound X in the manufacture of a medicament for a specified therapeutic use”: see Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50; 253 CLR 284 at [248] and Otsuka at [101].
The Full Federal Court in Commissioner of Patents v AbbVie Biotechnology Ltd (AbbVie)[54] came to the same conclusion, and provided more detail about the steps of the process:
“Speaking broadly, such claims are, in form, directed to the use of a substance in the manufacture of a medicament to be administered for a specified therapeutic purpose. An invention in this form is appropriately characterised as a ‘method or process’, not as a ‘product’: Otsuka at [120].”[55]
“They are method or process claims which, in this connection, exhibit a dual character. First, they are directed to a method or process in which a substance is used to produce a medicament. Secondly, they have an additional method or process element constituted by a specific purpose to which the medication is to be used.”[56]
[54] [2017] FCAFC 129 at [15].
[55] AbbVie at [15].
[56] AbbVie at [58]
I accept that Swiss type claims are directed to a method, wherein the method involves the preparation of the medicament with the intention of using it for the specific purpose recited in the claim. At the hearing there was some discussion of whether the phrase “for the provision of an anaesthetic effect” was defining a mere suitability for the provision of an anaesthetic effect, or an intention to provide an anaesthetic effect. Such a construction would be inconsistent with the normal meaning of a Swiss type claim. I see no reason to depart from the normal meaning, and thus the proper construction of claim 1 is that it is directed to a method for the preparation of a medicament, where the medicament is intended to be used to achieve an anaesthetic effect. But in whose mind does the intention to use the medicament as an anaesthetic need to arise? Does the manufacturer need to form the requisite intention when manufacturing the medicament? Does the general practitioner or pharmacist need to form the requisite intention when prescribing or selling the medicament? Does the patient need to form the requisite intention when consuming the product? In most cases all of these persons would have the same intention, but where that is not the case at least one of these persons must have the necessary intention.
As such, claim 1 defines a method, wherein the method is the manufacture of the medicament (a composition comprising DCBA in a combination with a compound selected from the group consisting of AMC, CPC, HT and HR) with an intention to use the medicament to provide an anaesthetic effect.
“anaesthetic effect”
The medicament is for the provision of an anaesthetic effect. The term anaesthetic is not explicitly defined in the specification. The Applicant argues that an anaesthetic effect is “something that provides a numbing effect or an effect of a loss or absence of sensation.”[57] The Macquarie Dictionary defines anaesthesia as “general or local insensibility, as to pain and other sensation, induced by certain drugs”, and anaesthetic as “relating to or causing physical insensibility.”
[57] Applicant’s Written Submissions at [52].
The specification uses the term in this way:
“Local anaesthetics numb the area they are in contact with and provide temporary relief.”[58]
“Anaesthesia is generally considered to be the loss or absence of sensation or feeling. The term is commonly used to describe a reversible process which allows operations and painful or unpleasant procedures to be performed without distress to the patient. In contrast analgesia refers to drugs which temporarily relieve or abolish pain. Unlike local anaesthetics, they produce no sensory or motor blockade stopping the activity in the sensory or motor nerves respectively that supply a part of the body.”[59]
[58] Specification at page 2, lines 11 and 12.
[59] Specification at page 2, lines 18-23.
Professor Christie defines anaesthesia as “the absence, partial or complete, of sensation”,[60] Mr Ford and Professor Adams define an anaesthetic effect as “a reversible loss of sensation”,[61] Dr Conos defines an ‘anaesthetic effect’ as “the absence of sensation”[62] and Ms Trieu defines anaesthesia as a “numbing effect”.[63]
[60] Christie-2 at [6].
[61] Ford at [25]; Adams-3 at [45].
[62] Conos at [25].
[63] Trieu-1 at [20].
I am satisfied that the specification is based on an anaesthetic effect as a reversible loss or absence of sensation or feeling (i.e. a numbing effect).
The Opponent submits that the anaesthetic effect in claims 1 to 6 is not limited to a local anaesthetic effect (in contrast with claims 7 to 19) and includes both a local and general effect.[64] It is noted that independent claims 1 and 2 define the provision of an “anaesthetic effect”, whereas independent claims 7 and 8 define a “local anaesthetic effect” and independent claims 12, 13, 17 and 18 define a method of “locally anaesthetising.” A general anaesthetic is not defined in the specification. Professor Christie is the only declarant who gives a definition of general anaesthetic as “the absence of sensation in the entire body and is usually associated with complete loss of consciousness.”[65] Professor Christie further notes that the mechanisms of action of general anaesthetics are still incompletely understood.[66] A general anaesthetic is to be contrasted with a local anaesthetic which acts at the pain source, “resulting in the inhibition of the transmission of a painful stimulus to the brain.”[67] I am satisfied that the specification draws a distinction between an anaesthetic effect and a local anaesthetic effect, and an anaesthetic effect includes a local or general anaesthetic effect.
[64] Opponent’s Written Submissions at [64].
[65] Christie-2 at [7].
[66] Christie-2 at [7].
[67] Adams-2 at [39].
I consider that an anaesthetic effect is a reversible loss or absence of sensation or feeling (partial or complete), either locally or generally.
Which compounds provide the anaesthetic effect?
The Opponent submits that claim 1 has two alternate constructions. One construction is that it is the combination of compounds in the medicament which provides the anaesthetic effect.[68] The alternate construction is that DCBA exhibits an anaesthetic effect and AMC, CPC, HT or HR need only provide, at a minimum, an antibacterial effect, i.e. the AMC, CPC, HT or HR need only be capable of providing an anaesthetic effect.[69] Under the latter construction of claim 1 the anaesthetic effect of the medicament can be mediated by DCBA alone.[70]
[68] Opponent’s Written Submissions at [61].
[69] Opponent’s Written Submissions at [62].
[70] Opponent’s Written Submissions at [62].
The Applicant prefers a construction wherein the hypothetical skilled addressee would construe claim 1 to relate to the use of DCBA in combination with AMC, CPC, HT and HR to make a medicament to give an anaesthetic effect.[71] The Applicant notes that the data in the specification shows that DCBA, AMC, CPC, HT and HR all exhibit an anaesthetic effect, and further notes that the words used in claim 1 recite that it is the medicament that provides the anaesthetic effect.[72]
[71] Applicant’s Written Submissions at [63].
[72] Applicant’s Written Submissions at [59].
The answer to the construction lies in the words of the claim. The claim concludes with the words “the preparation of a medicament [emphasis added] for the provision of an anaesthetic effect.” I consider that the words of claim 1 are clear, and it is the medicament as a whole that provides the anaesthetic effect.
There was some brief discussion at the hearing that due to the word “comprising”, a possible construction is that the anaesthetic effect is produced by a compound other than those explicitly defined. I do not consider this is a reasonable construction. The clear implication of the words is that the anaesthetic effect arises from the named compounds, and not from an undefined compound.
Construction of claim 2
Claim 2 is the second independent claim. It reads:
“The use of 2,4-dichlorobenzyl alcohol in a combination with amylmetacresol for the preparation of a medicament for the provision of an anaesthetic effect.”
My conclusions in relation to claim 1 apply equally to claim 2. Claim 2 defines a method, wherein the method is the manufacture of the medicament (a composition comprising DCBA and AMC) with an intention to use the medicament to provide an anaesthetic effect.
Construction of claim 7
Claim 7 is the third independent claim. It reads:
“A method of obtaining a local anaesthetic effect in a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol which exhibits an anaesthetic effect, wherein 2,4-dichlorobenzyl alcohol is in combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol.”
This claim requires consideration of several terms.
“obtaining”
The Macquarie Dictionary defines obtain as:
“1. To come into possession of; get or acquire; procure, as by effort or request.”
At the hearing, the Applicant submitted that the word obtaining in the context of “obtaining a local anaesthetic effect” should be understood as requiring a desire to obtain an anaesthetic effect. The alternative is that the anaesthetic effect is achieved, regardless of whether it was intended. Both interpretations can be seen as consistent with the definition in the dictionary. While I can see the merit in both points of view, I consider that the language of the claim suggests an intention to achieve an anaesthetic effect. The claim expression “method of obtaining” an anaesthetic effect suggests that the purpose of the method is to obtain the effect. It would be curious to describe a method as “obtaining” an effect that was not the purpose of the method. The alternative is that the “obtaining” is merely descriptive of the field of the invention, but this strikes me as an artificial way to view the claim. I am satisfied that it is more reasonable to view the claim as requiring an intention to obtain a local anaesthetic effect.
Which compounds provide the anaesthetic effect?
In contrast to claim 1 and claim 2, claim 7 provides a different statement about the anaesthetic effect:
“administering a composition comprising 2,4-dichlorobenzyl alcohol which exhibits an anaesthetic effect”.
This expression could be understood as stating that the composition as a whole exhibits an anaesthetic effect, or that the DCBA exhibits an anaesthetic effect. The Applicant submits that the PSA would construe claim 7 as relating to a method of obtaining a local anaesthetic effect using DCBA in combination with AMC, CPC, HT or HR,[73] and that:
“[i]t is clear from a reading of the specification as a whole that it is the composition that exhibits an anaesthetic effect. The composition comprises DCBA and AMC, CPC, HT or HR and each of these compounds is stated in the specification to have an anaesthetic effect. On this basis, it is evident that the positive recitation of DCBA having an anaesthetic effect does not mean that AMC, CPC, HT and HR do not have an anaesthetic effect.”[74]
[73] Applicant’s Written Submissions at [74].
[74] Applicant’s Written Submissions at [75].
I consider it is unnecessary to consider the specification as a whole, as the words of the claim are sufficiently clear. The composition comprises DCBA, and the composition exhibits an anaesthetic effect. The claim does not specify which components of the composition provide the anaesthetic effect. While it is clear from reading the specification as a whole that each of DCBA, AMC, CPC, HT and HR are stated to exhibit an anaesthetic effect,[75] this requirement does not appear in the claim.
[75] Specification at Table 1; page 18, line 17 – page 20, line 23.
“local anaesthetic effect”
The specification states that “[l]ocal anaesthetics numb the area they are in contact with and provide temporary relief.”[76] Neither the Macquarie Dictionary, nor the definitions of the declarants Adams,[77] Conos,[78] or Christie[79] depart from this understanding. I am satisfied that the phrase “local anaesthetic effect” should be construed as the reversible loss (partial or complete) of sensation or feeling (i.e. a numbing effect), wherein the numbing effect is achieved in a particular part of the body.
[76] Specification at page 2, lines 11 and 12.
[77] Adams-2 at [39].
[78] Conos at [25].
[79] Christie-2 at [7].
Construction of claim 8
Claim 8 is the fourth independent claim. It reads:
“A method of obtaining a local anaesthetic effect in a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol which exhibits an anaesthetic effect, wherein 2,4-dichlorobenzyl alcohol is in combination with amylmetacresol.”
The conclusions in relation to claim 7 apply equally to claim 8. Claim 8 defines a method comprising administering to a patient a composition comprising DCBA and AMC, wherein a local anaesthetic effect is both intended and produced in the patient.
Construction of claims 12 and 13
Claim 12 is the fifth independent claim. It reads:
“A method of locally anaesthetising a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol in combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol, wherein the 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect.”
Claim 13 is the sixth independent claim. It reads:
“A method of locally anaesthetising a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol and amylmetacresol, wherein the 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect.”
In contrast to claims 7 and 8, there is no reference to “obtaining” an anaesthetic effect. This suggests that these claims merely require achieving an anaesthetic effect, regardless of whether there is an intention. While the verb “anaesthetising” might itself suggest an intention, as it is a local anaesthetic effect I do not consider that an intention is necessary. I am not satisfied that an intention to achieve an anaesthetic effect is a feature of the claim.
“locally anaesthetising”
The term local anaesthetic effect was construed previously. The term “locally anaesthetising” is construed in a similar manner as a reversible loss of sensation or feeling (i.e. anaesthetising) in a particular part of the body (i.e. locally). There is no reason in the specification or in the evidence of the declarants to depart from this construction.
These claims state “wherein the 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect”. The plain meaning of this expression is that the DCBA produces an anaesthetic effect. It is immaterial whether any of the other components also produce an anaesthetic effect.
Construction of claims 17 and 18
Claim 17 is the seventh independent claim. It reads:
“A method of locally anaesthetising the throat of a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol in combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol wherein 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect, and wherein the composition is in a form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, or tablet.”
Claim 18 is the eighth independent claim. It reads:
“A method of locally anaesthetising the throat of a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol in combination with amylmetacresol, wherein 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect, and wherein the composition is in a form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, or tablet.”
Consistent with the construction of claims 12 and 13, “locally anaesthetising the throat of a patient” is construed as a reversible loss of sensation or feeling in the throat of a patient. Similarly, consistent with the construction of claims 12 and 13, it is also considered that the DCBA produces an anaesthetic effect. Furthermore, claims 17 and 18 are further limited to the defined forms of the composition (i.e. a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, or tablet).
Manner of Manufacture
Section 18(1)(a) of the Act requires that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. The High Court in National Research Development Corporation v Commissioner of Patents (NRDC)[80] laid out the proper question for determination when considering manner of manufacture as:
“Is this a proper subject according to the principles which have developed for the application of s. 6 of the Statute of Monopolies?”[81]
[80] [1959] HCA 67; 102 CLR 252.
[81] NRDC at [269].
With this at the fore of their considerations in respect of a claim to a process for eradicating weed from a stretch of land, the High Court in NRDC described subject matter that would be considered patentable:
“The point is that a process, to fall within the limits of patentability which the context of the Statute of Monopolies has supplied, must be one that offers some advantage which is material, in the sense that the process belongs to a useful art as distinct from a fine art ... that its value to the country is in the field of economic endeavour.”[82]
[82] NRDC at [275].
More recently, it has been made clear that the assessment of whether a claimed invention is a manner of manufacture is one of substance rather than form:
“Whatever words have been used, the matter must be looked at as one of substance and effect must be given to the true nature of the claim.”[83]
[83] D'Arcy v Myriad Genetics Inc [2015] HCA 35; 258 CLR 334 (Myriad) at [144].
The Applicant submits that the present case is analogous with NRDC, where:
“the inventors found that certain known anti-bacterial compounds (DCBA, AMC, CPC, HT and HR) can be used to provide a previously unknown anaesthetic effect … [and] that here, as in NRDC, a new economic use of an artificial substance has been claimed.”[84]
[84] Applicant’s Further Written Submissions at [10].
The High Court in NRDC, citing with approval the view expressed by Lindley LJ in Lane Fox v Kensington and Knightsbridge Electric Lighting Company,[85] stated:
“a man who discovers that a known machine (his Lordship might equally have said a known substance) can produce effects which no one before him knew could be produced by it has made a discovery, but has not made a patentable invention unless he so uses his knowledge and ingenuity as to produce either a new and useful thing or result, or a new and useful method of producing an old thing or result.”[86]
[85] (1892) 3 Ch. 424.
[86] NRDC at [8].
However, no general definition can be given as to what constitutes a discovery as opposed to an invention. The Court in NRDC stated:
“The truth is that the distinction between discovery and invention is not precise enough to be other than misleading in this area of discussion. There may indeed be a discovery without invention - either because the discovery is some piece of abstract information without any suggestion of a practical application of it to a useful end, or because its application lies outside the realm of ‘manufacture’.”[87]
[87] NRDC at [8].
Consistent with these authorities, the approach I will take here is to determine what is the substance of the claims, and whether or not the substance is patentable subject matter. I note that the substance of the claim is not necessarily the subject matter of the claim as defined by the words of the claim.
What is the subject matter of the claims?
Claims 1 and 2 are Swiss-type method claims. I have previously found that claim 1 defines a method, wherein the method is the manufacture of the medicament (a composition comprising DCBA in a combination with a compound selected from the group consisting of AMC, CPC, HT and HR) with an intention to use the medicament to provide an anaesthetic effect. Similarly, claim 2 defines a method, wherein the method is the manufacture of the medicament (a composition comprising DCBA and AMC) with an intention to use the medicament to provide an anaesthetic effect.
Claims 7 and 8 define methods of obtaining a local anaesthetic effect, comprising administering to a patient a composition comprising DCBA and any one of AMC, CPC, HT and HR, or a composition comprising DCBA and AMC respectively.
Claims 12 and 13 define methods of locally anaesthetising a patient, comprising administering to a patient a composition comprising DCBA and any one of AMC, CPC, HT and HR, or a composition comprising DCBA and AMC respectively.
Claims 17 and 18 define methods of locally anaesthetising the throat of a patient, comprising administering to a patient a composition comprising DCBA and any one of AMC, CPC, HT and HR, or a composition comprising DCBA and AMC respectively, wherein the composition is in a form of a lozenge, gel, spray, capsule, pastille gum, dissolving granules, gargle, drink, liquid-shots, or tablet.
What is the substance of the claims?
When determining the substance of the invention it is important to consider the claimed invention as a whole, not just the individual parts. At the hearing, I asked whether the substance of the invention in the opposed specification could be the discovery that Strepsils® lozenges produce an anaesthetic effect. The Applicant submits that from a fair reading of the specification, the substance of the invention is the new use of the known anti-bacterial compound DCBA in combination with the known anti-bacterial compounds AMC, CPC, HT and HR to provide a previously unknown anaesthetic effect.[88] The Applicant further submits that this substance lies within the established principles of what constitutes a patentable invention (i.e. a second medical use) and it is not in the category of claim that is merely a scheme, plan, rules of gameplay, intellectual or genetic information.[89]
[88] Applicant’s Further Written Submissions at [15].
[89] Applicant’s Further Written Submissions at [23].
The Applicant also argues that the discovery in the present case is that DCBA, AMC, CPC, HT and HR have anaesthetic properties, and the practical application of that discovery is the claimed use of the compounds to provide anaesthesia and to methods of obtaining an anaesthetic effect or anaesthetising a patient.[90]
[90] Applicant’s Further Written Submissions at [27].
I consider that the Applicant’s submission is correct. The substance of the claims is the use of known compositions to provide an anaesthetic effect. The substance of the claims is not a mere discovery, as the claims define a practical application of the discovery that DCBA, AMC, CPC, HT and HR have anaesthetic properties. It follows that I am satisfied that the invention as claimed in all claims is a manner of manufacture in light of Myriad.
Microcell
Another formulation of the manner of manufacture requirement is found in Commissioner of Patents v Microcell Ltd:[91]
“We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter of a patent.”
[91] (1959) 102 CLR 232 (Microcell) at 251.
The Opponent seeks to apply Microcell, arguing that the present invention is no more than the use of a well known composition (Strepsils® lozenges) for a purpose which was also well known (treating sore throats).[92] The Applicant disagrees arguing that the Opponent has provided no evidence to suggest that a skilled addressee on reading the specification would conclude that these compounds were known anaesthetics at the time of the invention.[93] The Applicant further submits that anaesthetic properties of DCBA, AMC, CPC, HT and HR were not common general knowledge and the Opponent has provided no evidence to suggest that they were.[94] More specifically in relation to Strepsils® lozenges, the Applicant submits that the Opponent has not provided any evidence that at the priority date the AMC and DCBA in Strepsils® lozenges could provide an anaesthetic effect. The Applicant cites the evidence of Dr Conos who states “I am not aware that [AMC and DCBA] have any other useful effect in the context of sore throat [sic] such as anaesthesia or analgesia.”[95] The Applicant concludes by submitting that the use of DCBA and AMC (as contained in Strepsils® lozenges) to provide an anaesthetic effect, takes advantage of the previously unknown anaesthetic properties of DCBA and AMC, and therefore this new use is patentable.
[92] Opponent’s Written Submissions at [144].
[93] Applicant’s Written Submissions at [102].
[94] Applicant’s Written Submissions at [104].
[95] Conos at [29].
I agree with the Applicant that there is nothing in the specification or in the common general knowledge to suggest that it was known that any of DCBA, AMC, CPC, HT or HR provide an anaesthetic effect. The invention is not merely the use of the composition to treat sore throats, but the use of the composition to achieve an anaesthetic effect. It follows that the Opponent has not shown that the present invention merely makes use of known properties of the compounds, and consequently there is no lack of manner of manufacture by analogy with Microcell.
Collocation
It has long been held that the mere collocation of known integers having no working interrelationship, or potential working interrelationship, is not a manner of manufacture:
“It is accepted as sound law that a mere placing side by side of old integers so that each performs its own proper function independently of any of the others is not a patentable combination, but that where the old integers when placed together have some working inter-relation producing a new or improved result then there is patentable subject-matter in the idea of the working inter-relation brought about by the collocation of the integers.”[96]
[96] British Celanese Ltd. V Courtaulds Ltd. 52 RPC 171 at 193-194.
The Opponent argues that Strepsils® lozenges comprising AMC and DCBA were an unpatentable collocation of known integers.[97] While I agree that the ingredients of Strepsils® lozenges were known at the priority date, the opposed claims do not define the compositions of Strepsils® lozenges per se. Claims 1-6 define Swiss-type methods, claims 7-11 define methods of obtaining a local anaesthetic effect, and claims 12-19 define methods of locally anaesthetising a patient. As such, none of the opposed claims define merely a collocation of known integers. It follows that I am not satisfied that the invention as claimed is a mere collocation.
[97] Opponent’s Written Submissions at [142].
Overall it has not been shown that the invention is not a manner of manufacture.
Utility
Section 18(1)(c) of the Act requires that for an invention to be patentable it must be useful. This requirement was expressed in the following manner in Ranbaxy Australia PtyLtd v Warner-Lambert Company LLC[98]:
“Under ss 138 and 18(1)(c) of the 1990 Act, it is a ground of invalidity if the claimed invention is not useful ‘so far as claimed in any claim’. If the claimed invention does what it is intended by the patentee to do and the end obtained is itself useful, the invention is useful within the meaning of s 18(1)(c) … As to the first aspect, the invention as claimed must attain the result promised by the patentee”.
[98] [2008] FCAFC 82; 77 IPR 449 at [141].
It is also clear from the authorities that the test for utility does not call for an evaluation of the performance of the invention compared to other prior art devices:
"If an invention does what it is intended by the Patentee to do, and the end attained is itself useful, the invention is a useful invention. A patent for such an invention cannot be held bad for want of utility by comparing it with other known methods or things which may be preferred to it." [99]
[99] Fawcett v Homan (1896) 13 RPC 398 at 405.
In Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd,[100] the Full Court of the Federal Court distilled the basic principles of inutility down to two questions, which are:
1. What is the promise of the invention derived from the whole of the specification?
2. By following the teaching of the specification, does the invention, as claimed in the patent, attain the result promised for it by the patentee?
[100] [2016] FCAFC 29 at [121].
Further, everything that is within the scope of a claim must attain the result promised for the invention by the patentee.[101]
[101] See Ronneby Road Pty Ltd v ESCO Corporation [2016] FCA 588 at [65] – [66].
What is the promise of the invention according to the specification?
The Opponent submits that the promise of the invention is that either DCBA alone or DCBA in combination with AMC (or CPC, HT or HR) provides an anaesthetic effect.[102] The Applicant submits that the inutility argument falls at the first hurdle as the opposed application makes no promise, and therefore there is no promise that is not met.[103] I disagree; the promise can be derived from reading the specification as a whole - a medicament comprising DCBA in combination with any one of AMC, CPC, HT or HR, wherein the medicament has a local anaesthetic effect.[104]
[102] Applicant’s Written Submissions at [147].
[103] Applicant’s Written Submissions at [193].
[104] Specification at page 1, lines 4-6; page 3, lines 3-6; page 3, lines 17-19.
Does the invention as claimed attain the promise of the invention?
The Opponent argues that the promise of the invention is not attained as the specification uses an inapplicable model to assess the ability of the compounds to provide an anaesthetic effect.[105] The Applicant’s argument is that the Opponent’s experts do not demonstrate clearly, unequivocally and without question that the compounds of the opposed specification are not anaesthetics.[106] The Opponent relies on evidence from its experts that the data provided in the specification fails to establish that the compounds tested would have an anaesthetic effect in vivo. The Opponent argues that the data fails to demonstrate that the compounds actually cause anaesthesia for several reasons.
[105] Opponent’s Written Submissions at [147].
[106] Applicant’s Written Submissions at [199] and [202].
Firstly, the Opponent submits that Nav1.2 sodium channels are not a suitable model for testing the effects of a local anaesthetic.[107] Professor Lynch provided evidence that most small Nav channel blocker drugs are non-selective (i.e. promiscuous) across the whole spectrum of Nav channel isoforms,[108] that Nav1.7, 1.8 and 1.9 channel isoforms are pain targets and if you block them you can reduce pain and induce local anaesthesia,[109] and concludes that compounds that block the Nav1.2 channel isoform will due to their promiscuous nature, generally also block the Nav1.7, Nav1.8 and Nav1.9 channels.[110] Professor Lynch uses the example of lidocaine which is a very well-known local anaesthetic that is a non-specific blocker of all Nav channels, to demonstrate this.[111] Similarly, Dr Leuwer’s evidence states that any suggestion that the Nav1.2 channel is unsuitable for measuring whether a compound has a local anaesthetic effect is incorrect.[112] The Opponent seeks to discredit Dr Leuwer on this point, submitting that there is a concession in the Bucholz paper (of which he is an author) that the Nav1.2 isoform is not relevant to the generation of analgesia.[113] However, this point is moot as all parties agree that analgesia is produced by a different mechanism than anaesthesia. Professor Adams’ evidence also states that blocking Nav1.2 does not necessarily translate to blocking Nav 1.7, 1.8 or 1.9 which are known pain targets.[114] Professor Adams further states that “it is not impossible for the compounds tested to provide an anaesthetic effect without being ‘selective’ for Nav1.3, Nav1.7, Nav1.8 and Nav1.9.”[115] Professor Christie’s evidence cites JWL-12, which discloses compounds with specificity for Nav1.8, as evidence against the promiscuity of small Nav channel blocker drugs.[116]
[107] Opponent’s Written Submissions at [151]; Adams-1 at [17] and [25]; Christie-3 at [6.1] and [9.3].
[108] Lynch at [9].
[109] Lynch at [32].
[110] Lynch at [33].
[111] Lynch at [105].
[112] Leuwer at [2].
[113] Opponent’s Written Submissions at [153].
[114] Adams-3 at [19].
[115] Adams-1 at [24].
[116] Christie-3 at [27].
Secondly, the Opponent submits that none of the compounds tested in the opposed application bind to Nav1.2 isoform in a use-dependent manner,[117] and that use-dependent (accumulative) block of the relevant Nav channels is required for an effective local anaesthetic.[118] The evidence of Professor Christie suggests that while use-dependent block would increase the confidence that a candidate compound would be an effective local anaesthetic, he also notes that some local anaesthetics do not exhibit good use-dependent block.[119]
[117] Opponent’s Written Submissions at [160]; Christie-3 at [8].
[118] Opponent’s Written Submissions at [155]; Christie-2 at [8] and [22]; Christie-3 at [34.4] and [48].
[119] Christie-3 at [9.5.2].
Thirdly, the Opponent submits that there is no basis for extrapolating the data provided in the opposed application to conclude that the compounds tested actually cause anaesthesia without causing toxicity.[120] Professor Christie’s evidence suggest that in vitro blocking experiments do not provide certainty that the compounds tested would behave safely and effectively as anaesthetics in vivo.[121] Professor Christie concludes that the ‘reversibility’ of the blocking capacity of the compounds tested is questionable,[122] and the suggestion that some drugs are ‘sticky’ as an explanation for residual block is trite and incorrect, and that there are many possible reasons for failure to washout (e.g. poisoning proteins, irreversible binding etc.).[123] Professor Adams agrees,[124] suggesting that inhibition of Nav currents could be attributable to toxicity of the drug, resulting from incomplete washout and potentially leading to cell death. The evidence of Professor Adams supports the assertion that the capacity of a compound to modulate a sodium channel in vitro is not indicative or predictive of whether it has the capacity to act as an anaesthetic in vivo.[125] Professor Adams points to the fact that zinc and tetrodotoxin (TTX) have the capacity to modulate action potentials in sodium channels in vitro, yet neither are suitable as anaesthetics because of toxicity and adverse drug reactivity.[126] Professor Christie also supports this view.[127] The alternate view is taken by Professor Lynch, who states that residual block is the kind of result that is standard for drugs that are a bit sticky and don’t wash out completely, and such partial wash out is not of great concern from a clinical perspective.[128]
[120] Christie-3 at [6.2], [6.4], [25] and [57]; Adams-3 at [46].
[121] Christie-3 at [36].
[122] Christie-3 at [29].
[123] Christie-3 at [32].
[124] Adams-3 at [34].
[125] Adams-3 at [11].
[126] Adams-3 at [11.1]-[11.4] in view of JWL-10 exhibited by Professor Lynch.
[127] Christie-3 at [18.2].
[128] Lynch at [85].
100. In Apotex Pty Ltd v AstraZeneca AB (No 4)[129] Jagot J pointed out that lack of utility requires evidence, not just speculation:
[129] [2013] FCA 162; 100 IPR 285 at [352].
"Ultimately, an asserted lack of utility must be established by appropriate evidence, not be mere speculation that the invention will not work or meet the promise set out in the specification."
101. In my view, the evidence provides competing scientific opinion on whether the medicament of the invention would, as a matter of fact, provide an anaesthetic effect. While I note the Opponent’s objections to the evidence of Professor Lynch,[130] I consider that Professor Lynch’s expertise would be representative of the hypothetical team representing the PSA. I will weigh Professor Lynch’s evidence in the usual manner. As noted by the Applicant, Yates J in Otsuka refused to accept the invitation to decide a scientific controversy based on the literature in evidence, and the witnesses’ opinions on that literature.[131] I too will not accept such an invitation.
[130] Christie-3 at [13]; Adams-3 at [4]-[6].
[131] Applicant’s Submissions at [211].
102. It is arguable that the data provided in the specification cannot establish that the promise of the invention is met. On the other hand, there is insufficient evidence to establish that the promise of the invention is not met. The latter is the test for a lack of utility. The onus is on the Opponent to show that the promise of the invention is not met, and the evidence provided by the Opponent has failed to discharge this onus. If follows that it has not been shown that any of claims 1-19 lack utility.
Novelty
103. It is well established that the general test for anticipation is the reverse infringement test. The classic formulation of this test is that given by Aicken J:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement.”[132]
[132] Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 235.
104. This test is satisfied if the alleged anticipation discloses all the essential features of the invention claimed.[133] Australian Courts have followed the principles established in General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd[134] where it was stated:
[133] Nicaro Holdings Pty Ltd v Martin Engineering Company [1990] FCA 40; 16 IPR 545 at 549.
[134] [1972] RPC 457 at 485 – 486.
“If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee's claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented: Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. ((1908) 25 R.P.C. 428 at 457, line 34, approved in B.T.H. Co. Ltd. v. Metropolitan Vickers Electrical Co. Ltd. (1928) 45 R.P.C. I at 24, line I). A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”
105. More recently the Full Federal Court in Novozymes A/S v Danisco A/S[135] stated that a prior disclosure will only invalidate a claim if by carrying out the instructions therein, the skilled addressee would, rather than could, have arrived at the claimed invention:
[135] [2013] FCAFC 6 at [177].
“Although General Tire is part of Australian jurisprudence in the relevant area, it must be accommodated to the terms of s 7(1) of the Patents Act, upon which everything depends. That is to say, the inevitability of outcome to which GeneralTire refers must be such as would arise from recourse to the information referred to in the section. At the expense of repetition, it is here useful to remind ourselves of what the Court of Appeal said in that case ([1972] RPC at 485-486):
… if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.
[Emphasis added]
This proposition is explicitly hypothetical. It is concerned not with what has happened or with what could have happened, but with what would have happened if the directions were carried out. As such, the proposition is in complete harmony with s 7(1), and with every other presently relevant aspect of the jurisprudence in this area. It is not the doing of it, nor even the ability to do it, that amounts to anticipation: it is the content of the information. If the information contains directions which, if carried out, would constitute an infringement of the patent in suit, the invention under the latter is not novel.”
Prior manufacture and use of Strepsils® lozenges
106. Strepsils® lozenges have been registered on the ARTG since at least 9 September 1991. The registered indication for Strepsils® lozenges is and always has been:
“For temporary relief from symptoms/discomfort of sore throats and minor mouth infections.”[136]
[136] Exhibit MC-20.
107. Strepsils® lozenges as registered on the ARTG comprise the following:
(i)1.2mg 2, 4 dichlorobenzyl (DCBA) and,
(ii)0.6mg amylmetacresol (AMC)[137]
[137] Exhibit MC-20.
108. Strepsils® lozenges and their use for the purposes for which they are registered on the ARTG are part of the common general knowledge of the relevant skilled person in Australia.[138]
[138] While this point does not seem to be in dispute, it is supported by the evidence of Ford at [23] and Conos at [35].
109. The Opponent’s argument is that the manufacture and use of Strepsils® lozenges in accordance with the ARTG registered indication since 1991 anticipates each claim of the opposed application.[139] The Applicant’s argument is that the manufacture and use of Strepsils® lozenges does not anticipate the claims of the opposed application, as the manufacture and use of Strepsils® lozenges does not disclose each and every integer of the opposed claims.[140] This argument is premised on the fact that at the priority date Strepsils® lozenges were known to contain the antiseptic compound DCBA and the disinfectant compound AMC to provide temporary relief from the symptoms of sore throats and minor mouth infections,[141] but there is no disclosure or suggestion in the ARTG entry that Strepsils® lozenges provide an anaesthetic effect.[142]
[139] Opponent’s Written Submissions at [78].
[140] Applicant’s Written Submissions at [117].
[141] Applicant’s Written Submissions at [119].
[142] Applicant’s Written Submissions at [120].
Mere Further Information
110. One limb of the Opponent’s novelty argument is that the claims of the opposed application do not encompass a new therapeutic use for a known compound, but provide mere information about an old use.[143] That is, assuming the data of the opposed application validates the theory of the mechanisms by which known antibacterials produce an anaesthetic effect, then this data is merely further explanation of the mechanism of action by which the Strepsils® lozenges comprising AMC and DCBA relieve the symptoms and discomfort of a sore throat.[144]
[143] Opponent’s Written Submissions at [81]; Otsuka at [304]-[306] and [321].
[144] Opponent’s Written Submission at [81].
111. Justice Yates in Otsuka at [321] stated:
“Novelty of invention is not provided merely because information given as part of the definition in a claim is new information … The provision of information that certain of the then known symptoms of schizophrenia are also associated with the 5-HT1A receptor is really no more than an elucidation of the action of known carbostyril compounds, including aripiprazole, in treating schizophrenia, and a contribution to knowledge of the possible aetiology of those particular symptoms. These accretions to knowledge, without more, do not provide novelty of invention. They are simply aspects of knowledge, albeit new information, about the then known therapeutic use (the treatment of schizophrenia) of a then known compound.”
112. The Opponent seeks to apply Otsuka to the current opposition, arguing that the discovery of the anaesthetic properties of Strepsils® lozenges, merely represents new aspects of knowledge for a known therapeutic use (i.e. treatment of sore throats, minor mouth infections and associated symptoms), and that this does not constitute a valid second medical use.[145] In response, the Applicant seeks to distinguish Otsuka on the basis that in that case the conditions being treated in the claimed method were a subset of the conditions which the prior art compound (aripiprazole) was known to treat, whereas in the present case anaesthesia (the second medical use) is not a subset of the known use (antiseptic). The Applicant seeks to further distinguish Otsuka by arguing that in Otsuka, unlike the present case, the active was acting on the same receptor and the physiological interaction or mechanism of action was the same. The Applicant submits that the Opponent has provided no evidence or explanation of the mechanisms of action of Strepsils® lozenges, and in the absence of a known anaesthetic compound, the mechanism of action of Strepsils® lozenges was known to be a result of the soothing action of the use of a lozenge.[146] In sum, the Applicant submits that the second medical use is the provision of an anaesthetic effect and not treatment of a sore throat.[147]
[145] Opponent’s Written Submissions at [88].
[146] Applicant’s Written Submission at [127].
[147] Applicant’s Written Submission at [125].
Inevitable Result
113. A second limb of the Opponent’s novelty argument is even if the alleged second medical use is the provision of an anaesthetic effect by Strepsils® lozenges, this use inevitably occurred since Strepsils® lozenges were first sold and used for the purposes defined in the ARTG registration.[148]
[148] Opponent’s Written Submissions at [96].
Application of the law to the facts
114. It is common ground that Strepsils® lozenges have been sold in Australia since at least 1991 and that these lozenges contain 1.2mg of DCBA and 0.6mg AMC, and that their registered indication is “for temporary relief from symptoms/ discomfort of sore throats and minor mouth infections.”
115. I will say a few words about the second medical use points. Where an invention is a second medical use it raises the question of whether the use is novel (and also inventive) in light of the first medical use. The answer depends on the facts of the case and importantly the proper construction of the claims. The second medical use aspect is not, of itself, a helpful means to analyse the ground.
116. As already discussed, claim 1 is directed to a method of manufacture of the medicament (composition comprising DCBA in a combination with a compound selected from the group consisting of AMC, CPC, HT and HR) with an intention to use the medicament to provide an anaesthetic effect. As a result, claim 1 is considered novel in light of the prior manufacture and use of Strepsils® lozenges, as no intention would be formed in the mind of the manufacturer of Strepsils® lozenges, a pharmacist or general practitioner recommending the use of Strepsils® lozenges, or a consumer of Strepsils® lozenges, that the Strepsils® lozenge would be used to provide an anaesthetic effect. The registered indication for Strepils® lozenges is to provide “temporary relief from symptoms/ discomfort of sore throats and minor mouth infections” and not to provide an anaesthetic effect. At the priority date Strepsils® lozenges were known to contain the antiseptic compound DCBA and the disinfectant compound AMC to provide temporary relief from the symptoms of sore throats and minor mouth infections.[149] In addition, the evidence of Ms Trieu states at [17] that “[p]rior to 15 November 2007, I consider lignocaine to be the anaesthetic that was most commonly known and used in Australia and is commonly seen in lozenges.” Therefore, before the priority date, a pharmacist or general practitioner when recommending Strepsils® would not have formed an intention that it would have provided a local anaesthetic effect. As a result it has not been shown that claim 1 lacks novelty in view of the prior manufacture and use of Strepsils® lozenges, and the same applies to claims 2-6.
[149] Applicant’s Written Submissions at [119].
117. Claim 7 is directed to a method of administering a combination of DCBA and one other of the defined compounds to a patient which is intended to, and does in fact, produce a local anaesthetic effect. The prior use of Strepsils® lozenges discloses a method of administering a composition of DCBA and AMC to a patient to relieve the symptoms of a sore throat. There is no suggestion that it was ever intended to obtain a local anaesthetic effect. It follows that it has not been shown that claim 7 lacks novelty. The same conclusion applies to claim 8.
118. Claims 12 and 13 are directed to a method of locally anaesthetising a patient. An intention to anaesthetise the patient is not necessary. The question is whether the evidence establishes that the prior use of Strepsils® will inevitably obtain a local anaesthetic effect.[150] The specification provides data that indicates that AMC and DCBA provide an anaesthetic effect.[151] The specification further provides an embodiment wherein DCBA is present in an amount of 1.2mg,[152] and AMC is present in an amount of 0.6mg.[153] This embodiment contains DCBA and AMC in the same amounts as contained in Strepsils® lozenges.
[150] See Novozymes A/S v Danisco A/S [2013] FCAFC 6.
[151] Specification at Figures 1-7 and 14-16; Table 1; page 19, lines 3-12; page 19, line 20-page 20, line 12.
[152] Specification at page 4b, lines 23-24
[153] Specification at page 4c, lines 1-2.
119. There is some evidence from the declarants that Strepsils® lozenges do not have the capacity to produce an anaesthetic effect. For example, according to Professor Christie’s evidence, there is nothing to suggest that Strepsils® lozenges have the capacity to produce anaesthesia in patients.[154] Similarly, Professor Adams states the low concentrations of AMC and DCBA in lozenges when taken orally is likely insufficient to result in blocking Navs.[155] The Applicant argues that the specification provides data that when extrapolated using theoretical modelling, indicates to a PSA that a combination of DCBA and AMC administered to a patient would produce an anaesthetic effect.
[154] Christie-3 at [7.2].
[155] Adams-3 at [21.3].
120. As already stated, the whole thrust of the specification is that an anaesthetic effect would be achieved using Strepsils® lozenges. The declarants express doubt whether this would be achieved. However, the declarants have not shown that an anaesthetic effect would not be achieved. In this situation I am satisfied that I should proceed on the basis that Strepsils® lozenges produce a local anaesthetic effect. It follows that claims 12 and 13 lack novelty in view of the prior use of Strepsils® lozenges.
121. Claims 14 and 15 are directed to the specific form of the composition, and include lozenges. It follows that these claims also lack novelty. Claim 16 is directed to the choice of patient, and the use is to treat various complaints such as a dry, scratchy, and painful throat. These are the well known uses of Strepsils® lozenges. It follows that claim 16 also lacks novelty.
122. Claims 17 and 18 are directed to locally anaesthetising the throat of a patient, wherein the anaesthetic effect is produced by the DCBA and the composition in a form that includes lozenges. It follows from what I said in relation to claims 12 and 13 and the appended claims that these claims lack novelty. Claim 19 is directed to a composition in the form of a lozenge. This claim also lacks novelty.
123. I conclude that claims 12 – 19 lack novelty in view of the prior use of Strepsils® lozenges.
WO 2007/110871
124. WO 2007/110871: WO 2007/110871 (designated D3) was published on 4 October 2007. Consequently it is part of the prior art base.
125. D3 is titled “Methods and Composition for Treating Sore Throat”. D3 discloses a method for treating, soothing or reducing the severity of a sore throat or other irritations of the throat for an extended period of time, especially during sleep, by administering a pharmaceutical composition in the back of the throat.[156] In addition D3 discloses a pharmaceutical composition formulated for local administration to the mouth or throat of a subject for treating, soothing or reducing the severity of a sore throat in the subject during sleep.[157] The composition comprises an oily vehicle which provides an oily coating to the throat of a subject, and an active ingredient in an amount effective to treat, sooth or reduce the severity of a sore throat.[158] The active ingredient is selected from the group consisting of an oil, a local anaesthetic, an antiseptic agent, and mixtures thereof.[159] D3 further describes that an advantage of the composition is that the oily vehicle coats the throat and the active ingredient provides relief, treats, and soothes the throat.[160] Furthermore, D3 discloses that the local anaesthetic can be DCBA,[161] and the antiseptic agent can be AMC.[162]
[156] D3 - Abstract.
[157] D3 at page 3, lines 29-31 .
[158] D3 at page 3, line 31 – page 4, line 2.
[159] D3 at page 4, lines 18-20.
[160] D3 at page 4, lines 4-6.
[161] D3 at page 5, line 17.
[162] D3 at page 5, line 26.
126. The Opponent submits that there are numerous disclosures in D3 of the suitability of DCBA as a local anaesthetic (see for example page 5, paragraph 4, page 6, paragraph 4, page 12, paragraph 2 and claims 4, 11, 40, 57, and 64),[163] and of the suitability of AMC as an antiseptic agent (see for example the last paragraph on page 5, paragraph 5 on page 6, page 12, paragraph 4 and claims 7, 13, 43, 49 and 60).[164] Therefore, the Opponent argues that D3 discloses a composition that would inherently and inevitably anticipate the claims of the opposed application.[165] The Applicant relies on the evidence of Ms Trieu who can find no enabling disclosure of a composition comprising DCBA as an anaesthetic in D3.[166] Ms Trieu’s evidence points to the fact that the only anaesthetic compound exemplified in D3 is benzocaine in Example 4.[167] Ms Trieu also questions whether all of the compounds listed on page 6, lines 15-22 and page 12, lines 7 to 14 would be classified as local anaesthetics, and she normally considers only the ‘caine’ compounds to be local anaesthetics.[168] Ms Trieu further references various ‘Drug Reference’ texts which fail to list DCBA as a local anaesthetic, to strengthen the lack of enablement argument.[169]
[163] Opponent’s Written Submissions at [101].
[164] Opponent’s Written Submissions at [102].
[165] See Adams-2 at [37] and Christie-2 at [66].
[166] Applicant’s Submissions at [138].
[167] Trieu-1 at [38].
[168] Trieu-1 at [36] and [38].
[169] Trieu-1 at [21] to [23] and Exhibit YT-5; Trieu-1 at [27] and Exhibit YT-6.
127. D3 discloses DCBA as one of thirty five possible local anaesthetics to be used as the active ingredient in the composition of the invention,[170] and AMC as one of eleven possible antiseptic agents to be used as the active ingredient in the composition of the invention.[171] In addition, the active ingredient may be any one of a number of oils.[172] The preferred local anaesthetic is benzocaine,[173] and the preferred antiseptic agents are tyrothricin, dequalinium chloride and boric acid (and not AMC).[174] D3 provides four examples. Example 1 provides dequalinium chloride (an antiseptic) as one of the active ingredients, Examples 2 and 3 provide only oils as the active ingredients, and Example 4 provides benzocaine (a local anaesthetic) and tyrothricin (an antiseptic) as some of the active ingredients. As such, D3 fails to provide any clear and unmistakeable directions to the combination of DCBA and AMC. This particular combination is one of many combinations disclosed in D3 and the disclosure of D3 directs the skilled addressee to use oils as the active ingredient in preference to either of DCBA or AMC. As a result, I am not satisfied that any of the claims lack novelty.
[170] D3 at page 5, lines 16-22.
[171] D3 at page 5, lines 25-29.
[172] D3 at page 5, lines 1-10.
[173] D3 at page 5, lines 23-24.
[174] D3 at page 5, lines 29-30.
Inventive Step
128. The test for whether an invention is obvious is whether it would have been a matter of routine to proceed to the claimed invention.
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.”[175]
[175] Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12; 148 CLR 262 at 286.
129. More recently, the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd[176] referred with approval to this approach and further held:
[176] [2002] HCA 59; 56 IPR 129 at 142-143.
“That way of approaching the matter has an affinity with the reformulation of the ‘Cripps question’ by Graham J in Olin Mathieson Chemical Corporation vBiorex Laboratories Ltd [1970] RPC 157. This court had been referred to Olin in the argument in Wellcome Foundation. Graham J had posed the question:
`Would the notional research group at the relevant date in all the circumstances directly be led as a matter of course to try [the claimed invention] in the expectation that it might well produce [the desired result]?'
That approach should be accepted.”
Common general knowledge
130. Common general knowledge is the background knowledge and experience available to all those working in the relevant art:
“The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[177]
[177] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; 144 CLR 253 at 292.
131. There was no dispute between the parties that the use of Strepsils® lozenges for the temporary relief from symptoms/discomfort of sore throats and minor mouth infections, is part of the common general knowledge of a PSA in Australia at the priority date of the present invention.
Problem
132. As discussed previously, I consider the problem to be the need for a ‘fast acting’ method to manage the discomfort associated with a sore throat. I consider that the same problem applies to each of the claims, which are directed to different solutions to this problem.
Prior manufacture and use of Strepsils® lozenges
133. Having regard to the problem, Strepsils® lozenges were widely used to manage the discomfort of sore throats. However, there is nothing in the ARTG Entry (which is equivalent in its level of disclosure to the prior use of Strepsils® lozenges) which would directly lead a PSA as a matter of course to use DCBA and AMC to provide an anaesthetic effect, with a reasonable expectation of success. This conclusion is supported by the evidence of Ms Trieu.[178] As a result, those claims that require an intention to produce an anaesthetic effect are considered inventive in light of the prior manufacture and use of Strepsils® lozenges. However, those claims that do not require an intention to obtain an anaesthetic effect (which are claims 12-19 that I previously found to lack novelty) would be arrived at as a matter of course, and consequently lack inventive step.
[178] Trieu-2 at [18].
WO 2007/110871 (D3)
134. I previously discussed the content of D3, and the fact that it discusses compositions for treating a sore throat that can contain DCBA and AMC. Clearly D3 is highly relevant. However, before going further it is necessary to consider whether it would have been ascertained.
135. The Opponent argues that given the similarity between the invention of D3 and that of the opposed application, D3 would have been ascertained, understood and regarded as relevant.[179] This is not sufficient to establish that D3 would have been ascertained. The Opponent’s written submissions develop an argument that patents would have been consulted because the opposed application contains references to patents, and Dr Leuwer (who is presented by the Applicant as a PSA) is an inventor. [180] This also is not a sufficient basis for me to infer that a PSA would have searched patents. The Opponent also points out that the Manual of Practice and Procedure says that examiners should generally proceed on the basis that it is reasonable to expect that a PSA would conduct a search of the patent literature.[181] In the context of an opposition, the expectation is that the opponent will provide evidence to support their case.
[179] Opponent’s Written Submissions at [132].
[180] Opponent’s Written Submissions at [125] and [126].
[181] Opponent’s Written Submissions at [124].
136. The Opponent has not provided evidence that a PSA would have searched patents. The Applicant has provided evidence of Ms Trieu that she would not consult patent literature in the normal course of her work, and that in her view pharmacists would not consult the patent literature when investigating drug alternatives to address a particular therapeutic issue in the normal course of their work.[182] I accept Ms Trieu’s evidence. That said, the PSA is a team of people that is not restricted to pharmacists.
[182] Trieu-1 at [35].
137. In the absence of evidence, delegates of the Commissioner have been cautious in finding that a document would have been ascertained. Transcend Medical, Inc v Glaukos Corporation[183] is a useful example. The delegate noted that it would be expected that a PSA would search the patent literature in a sophisticated technology, but that is not conclusive where the evidence indicates otherwise.
[183] [2015] APO 73.
138. In the present case I have evidence that a PSA would not search the patent literature, and no evidence to the contrary. The technology is a throat lozenge, which is not necessarily a highly sophisticated technology. While it would not be surprising if the PSA did search the patent literature, there is insufficient basis for me to conclude that they would conduct a patent search. The Opponent has not established that D3 would be ascertained. It follows that the Opponent has not shown that there is a lack of inventive step in light of D3.
Clarity
139. It is a requirement of section 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if a person could ascertain “whether or not what he proposes to do falls within the ambit of the claim.”[184]
[184] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60.
140. The Opponent argues that the claims are unclear due to there being two alternative constructions in which either DCBA alone or DCBA in combination with another compound provides the anaesthetic effect.[185] The Opponent points to the fact that claims 1 and 9 as originally filed encompass the use of one or more antibacterial compounds to provide an anaesthetic effect,[186] whereas amended claims 1 to 6 recite that it is the medicament which provides the anaesthetic effect, yet claims 7 to 19 recite that DCBA imparts the anaesthetic effect, and that DCBA is in combination with one of AMC, CPC, HT or HR.[187] The Applicant’s argument is that despite the fact that DCBA is specifically referred to as exhibiting an anaesthetic effect in the method claims 7 to 19,[188] there is no language in the method claims that excludes AMC, CPC, HT and HR from providing an anaesthetic effect.[189]
[185] Opponent’s Written Submissions at [181].
[186] Opponent’s Written Submissions at [182].
[187] Opponent’s Written Submissions at [183].
[188] Applicant’s Written Submissions at [236].
[189] Applicant’s Written Submissions at [235].
141. As noted in Flexible Steel Lacing Company v Beltreco Ltd:[190]
[190] [2000] FCA 890; (2000) IPR 331; cited with approval in Austal Ships Sales Pty Ltd v Stena Rederi Aktiebolag [2008] FCAFC 121; (2008) 77 IPR 229.
“The consideration is whether, on any reasonable view, the claim has meaning. In determining this, the expression in question must be understood in a practical, common sense manner.”
142. Previously I decided that it is possible to construe all of the terms in the claims, and determine the scope of the claims using a common sense approach. It follows that I am not satisfied that any of the claims lack clarity.
Fair Basis
143. Section 40(3) of the Act requires that the claims must be fairly based on the matter described in the specification. The test for fair basis was stated by the High Court as:
“the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”[191]
[191] Lockwood Security v Doric Products [2004] HCA 58 at [69]; 217 CLR 274.
144. The Opponent’s first fair basis argument is that claims defining a combination of DCBA and AMC are not fairly based as this combination has a reduced anaesthetic effect compared to AMC alone.[192] The Opponent submits that the 50µM/100µM combination of AMC/DCBA is inconsistent with what the specification, as a whole, describes as the invention (the use of antibacterials for the provision of an anaesthetic effect).[193] The Applicant’s response to this argument is that the specification merely states that the effect of that combination was significantly decreased, and that it does not say that the combination has no anaesthetic effect [emphasis added].[194]
[192] Opponent’s Written Submissions at [201].
[193] Opponent’s Written Submissions at [201].
[194] Applicant’s Written Submissions at [252].
145. From a reading the specification as a whole, it is clear that the combination of DCBA and AMC as an anaesthetic is a preferred embodiment of the invention, in particular as this combination is the only combination exemplified as a typical medicament or composition,[195] which both parties agreed was the best method of performance. While the specification states on page 13, lines 15-16 that the effect on fast inactivation of the 50 uM/100uM combination of AMC/DCBA was significantly decreased by the addition of DCBA compared to the effect of 50uM AMC alone, the specification puts forward a theory that the combination of both drugs leads to a ceiling effect of the local anaesthetic effect of AMC.[196] Thus the specification when read as a whole, does not disclose that the AMC/DCBA combination has no anaesthetic effect, but rather that it has an attenuated anaesthetic effect, and this combination, despite this attenuated effect is a preferred embodiment. There is a real and reasonably clear disclosure of the provision of an anaesthetic effect by the combination of DCBA and AMC. As a result, the claims are not considered to lack fair basis due to the DCBA/AMC combination purportedly having a lower anaesthetic effect.
[195] Specification at page 4d, lines 14-30.
[196] Specification at page 20, lines 11-12.
146. The Opponent’s second fair basis argument is that claims 1 and 2 are not fairly based as there is no limitation in claims 1 and 2 that the anaesthetic effect is a localised effect, and that the specification does not provide basis for the use of said antibacterial agents other than in a localised context.[197] I previously found that the scope of the term ‘anaesthetic effect’ in claims 1 and 2, could include a local or general anaesthetic effect. Throughout the specification, reference is made to the use of ‘local anaesthetics’. For example, the specification at page 2, lines 10-23, distinguishes ‘typical anaesthetics’ from analgesics, wherein the only typical anaesthetics discussed are benzocaine and lidocaine hydrochloride, which are both local anaesthetics. Page 19, lines 3-5 discusses the blocking potency of DCBA on sodium currents when compared to the local anaesthetic lidocaine. Page 19, lines 20-21 compares the binding affinity of AMC and HR to inactivated channels, with lidocaine-like local anaesthetics. Furthermore, the problem to be solved by the present invention is the need to quickly manage the discomfort associated with a sore throat, which is in the context of local pain relief. As a result, I consider that there is only a real and reasonably clear disclosure of the provision of local anaesthesia in the body of the specification, and claims 1-5, which include the provision of general anaesthesia within their scope, are not fairly based.
[197] Opponent’s Written Submissions at [207].
Full Description
147. The test for sufficiency of description under section 40(2)(a) of the Act is set out by the High Court as:[198]
[198] Kimberly-Clark Australia Pty Ltd v Arico Trading International PtyLtd [2001] HCA 8; 207 CLR 1 at [25].
“will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?”
148. The Opponent argues that the specification fails to enable the addressee of the specification to produce a composition capable of producing an anaesthetic effect over and above the effect inevitably achieved by use of a Strepsils® lozenge, without new invention or addition or prolonged study.[199] The Applicant argues that the invention is fully described as the specification describes compositions comprising DCBA and AMC, CPC, HT or HR and how to make them, and the specification states that these compositions provide an anaesthetic effect.[200]
[199] Opponent’s Submissions at [179].
[200] Applicant’s Submissions at [183].
149. I think it is clear that the specification fully describes compositions comprising DCBA and AMC, CPC, HT or HR.[201] As I have stated previously, I have insufficient evidence to conclude that the compositions described in the specification would not provide an anaesthetic effect. Therefore I consider that a PSA could make a composition comprising DCBA and AMC, CPC, HT or HR, in order to provide (or obtain) an anaesthetic effect. As such I am satisfied that the invention is fully described.
[201] Specification at page 4, line 26 – page 4e, line 6.
Conclusion
150. The opposition succeeds on the grounds of novelty with respect to claims 12-19, inventive step with respect to claims 12-19, and a lack of fair basis with respect to claims 1- 5.
151. I consider these matters can be overcome by amendment. I will allow the Applicant an opportunity to propose amendments.
Costs
152. It is normal in matters before the Commissioner that costs should follow the event. I see no reason to depart from that approach in the present case. I will award costs according to Schedule 8 against the Applicant.
Dr S. D. Barker
Deputy Commissioner of Patents
ANNEX: The claims of the application1. The use of 2,4-dichlorobenzyl alcohol in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol for the preparation of a medicament for the provision of an anaesthetic effect.
2. The use of 2,4-dichlorobenzyl alcohol in a combination with amylmetacresol for the preparation of a medicament for the provision of an anaesthetic effect.
3. The use as claimed in Claim 1 or 2, wherein the medicament is in the form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, tablet, or any other suitable form.
4. The use as claimed in Claim 3, wherein the medicament is in the form of a lozenge.
5. The use as claimed in any one of the preceding Claims, wherein the medicament has a base that comprises one or more components selected from sucrose, glucose, isomalt, maltitol, xylitol, mannitol.
6. The use as claimed in any one of the preceding Claims, wherein the medicament is used to treat sore throats, including dry, scratchy, inflamed, swollen, stabbing, burning and painful throats, or other areas of the mouth such as the gums or tonsils.
7. A method of obtaining a local anaesthetic effect in a patient compnsmg administering a composition comprising 2,4-dichlorobenzyl alcohol which exhibits an anaesthetic effect, wherein 2,4-dichlorobenzyl alcohol is in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol.
8. A method of obtaining a local anaesthetic effect in a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol which exhibits an anaesthetic effect, wherein 2,4-dichlorobenzyl alcohol is in a combination with amylmetacresol.
9. The method as claimed in Claim 7 or 8, wherein the patient is suffering from a sore throat including dry, scratchy, inflamed, swollen, stabbing, burning and painful throats, or other areas of the mouth such as the gums or tonsils.
10. The method as claimed in any one of claims 7 to 9, wherein the composition is in the form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, tablet, or any other suitable form.
11. The method as claimed in Claim 10, wherein the composition is in the form of a lozenge.
12. A method of locally anaesthetising a patient compnsmg administering a composition comprising 2,4-dichlorobenzyl alcohol in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol, wherein the 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect.
13. A method of locally anaesthetising a patient compnsmg administering a composition comprising 2,4-dichlorobenzyl alcohol and amylmetacresol, wherein the 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect.
14. The method of claim 12 or 13, wherein the composition is in a form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, or tablet.
15. The method of claim 14, wherein the composition is in a form of a lozenge.
16. The method of any one of claims 12 to 15, wherein the composition is used to treat sore throats, including dry, scratchy, inflamed, swollen, stabbing, burning and painful throats, or other areas of the mouth such as the gums or tonsils.
17 A method of locally anaesthetising the throat of a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol wherein 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect, and wherein the composition is in a form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, or tablet.
18. A method of locally anaesthetising the throat of a patient compnsmg administering a composition comprising 2,4-dichlorobenzyl alcohol in a combination with amylmetacresol, wherein 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect, and wherein the composition is in a form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, or tablet.
19. The method of claim 17 or 18, wherein the composition is in a form of a lozenge.
3
15
0